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FDA (Device enforcement)Recalled 2019-07-17closedclass ii

Becton Dickinson & Co.: Kit EXT Enteric Bacterial Panel; Catalog # 443812

Is my product affected?

Kit EXT Enteric Bacterial Panel; Catalog # 443812

  • UPC 00382904438128

Check against the official notice below — it lists the full affected range.

What happened

Becton Dickinson & Co. is recalling the BD MAX EXT Enteric Bacterial Panel (Catalog # 443812) because foil bags containing extraction tubes for BD MAX Reagent products may not have been sealed properly. A total of 715 units across three lots were affected and distributed throughout the United States, Puerto Rico, and multiple countries worldwide including Australia, Brazil, Canada, China, Japan, Mexico, and Singapore. The affected lots are: Lot # 9114557 (expiration 11/7/2020), Lot # 9126778 (expiration 11/17/2020), and Lot # 9129979 (expiration 11/22/2020).

The source document does not specify what action affected consumers should take in response to this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.

Details from the source

Reason for recall: The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly. Distribution: AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NH, NJ, NM, NV, NY, OH, OR, PA, PR, RI, SC, TN, TX, VA, WA, WI, WV Worldwide: Australia, Belgium, Brazil, Canada, Chile, China, Hong Kong, Japan, Korea, Mexico, Singapore, Taiwan Quantity: 715 units Lot/code info: Lot # 9114557; UDI (GTIN, DI+PI): (01)00382904438128 (17)201107(10)9114557(30)1; Exp: 11/7/2020 Lot # 9126778; UDI (GTIN, DI+PI): (01)00382904438128 (17)201117(10)9126778(30)1; Exp: 11/17/2020 Lot # 9129979; UDI (GTIN, DI+PI): (01)00382904438128 (17)201122(10)9129979(30)1; Exp: 11/22/2020

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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